Diet, HealthyNCT04348019
Effects of a Daily Time-Restricted Feeding Protocol on Diet Quality
A study testing Fasting in people with Diet, Healthy and Weight Change, Body, run by Arizona State University at 1 site in United States.
Trial summary
As a result of unhealthful lifestyle practices including nighttime ingestion and excess energy-dense food and beverage intake, college students are presenting with metabolic abnormalities and excess weight gain that increases their risk for chronic health conditions including cardiovascular diseases and type 2… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Weight Change, Body, Dyslipidemias
- What is being tested?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy (no unresolved medical condition)
- non-smoking (includes vaping)
- normal to under-active (< 420 minutes of activity/week; not training for or competing in sports events)
- college students (≥18 years old)
- free of acute illnesses or diagnosed chronic diseases (by self-report)
- waist circumference ≥ 80 cm for women, and ≥ 94 cm for men. Participants will not be excluded based on race/ethnicity or socioeconomic status.
Who cannot join
- participants who regularly fast for >12 hours/d or adhere to a fasting regimen (i.e., alternate day fasting, Ramadan-style fasting, 5:2 fasting) at the time of screening or within the past six months
- those with weight loss attempt(s) or weight change (≥ 5 lbs.) within the past six months (including pregnancy)
- those with a history of weight cycling (repeated weight loss and weight gain over time)
- those who currently work night-shifts (i.e., midnight to 6AM), and those unwilling to adhere to the protocol will be excluded from the trial
- pregnant or lactating women, and women not on prescription contraceptives (i.e., birth control pills, IUDs, and patches) (however, if a female applicant states her menstrual cycle is regular, the need to be on prescription contraceptives will be waived)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Official title: Mealtime Matters: An 8-wk Randomized-Controlled Trial to Examine the Effects of a Daily Time-Restricted Feeding Protocol on Diet Quality
As a result of unhealthful lifestyle practices including nighttime ingestion and excess energy-dense food and beverage intake, college students are presenting with metabolic abnormalities and excess weight gain that increases their risk for chronic health conditions including cardiovascular diseases and type 2 diabetes. Research has shown that prolonging nightly fasting intervals can result in health improvements in both animal models and human subjects. Time-restricted feeding (TRF), a form of intermittent fasting may offer an exciting, non-pharmacologic approach to improve cardiometabolic health in this population by restricting food intake to feeding windows that align with circadian biology.
Read the detailed description
This 8-wk randomized-controlled, parallel arm trial will examine the effects of a daily 18 h fast (TRF protocol) compared to a daily 8-h (CON protocol) on (1) diet quality, (2) cardiometabolic health, and (3) anthropometry in college students enrolled at ASU. Institutional Review Board (IRB) approval will be granted prior to recruitment and commencement of trial activities. Participants will be stratified by age, waist circumference, gender, and METS (activity score) and randomly assigned to one of two study arms: intervention and control. [Women will begin the trial within 5 days of menses.] Participants in the intervention arm of the study will consume food and beverages of their choice within one hour of waking and the feeding window will extend 6 hours. Beyond these hours, participants will observe a prolonged fast (i.e., an 18-h overnight fast). Participants in the control arm of the study will fast each night for 8 hours. During fasting hours, participants will only be permitted to consume non-caloric beverages (preferably water only but unsweetened and non-caloric coffee, tea, etc. will be permitted). Participants will adhere to their daily protocol for 8 weeks. Participants will not receive diet instruction other than 'to fast' and are told to maintain their typical physical activity patterns for the duration of the trial. Participants will choose one 'cheat-day' per week where they are excused from the fasting protocols; this day of the week will be consistent throughout the 8-week trial. Diet quality will be measured by the REAP-S questionnaire, 24-h recalls will be obtained by a registered dietitian via a three-step multiple-pass interview method, a registered nurse or radiology technician will obtain fasting blood draws for biomarkers, and trained research personnel will obtain measures of anthropometry.
- Conditions
- Diet, Healthy, Weight Change, Body, Dyslipidemias, Blood Pressure
- Being tested
- Fasting
- Keywords
- time restricted feeding, fasting, diet quality, body mass index, cardiometabolic biomarkers
- Medical subject headings
- Body Weight Changes, Dyslipidemias, Intermittent Fasting, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Fasting was defined as no foods or caloric beverages.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding | Experimental | Participants in the intervention arm of the study will consume food and beverages of their choice within one hour of waking and the feeding window will extend 6 hours. Beyond these hours, participants will observe a prolonged fast (i.e., an 18-h overnight fast). Receives: Behavioral: Fasting |
| Control | Placebo comparator | Participants in the control arm of the study will fast each night for 8 hours. Receives: Behavioral: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet quality
A REAP-S questionnaire will be completed for the previous week's intake during Trial Visits 1-3. The REAP-S questionnaire is a 16-item validated measure of diet quality whereby participants respond to questions that estimate the intake of fruits and vegetables, fiber, sugar, milk, fat, and dietary cholesterol. Responses of 'usually/often' will receive 1 point, 'sometimes' will receive 2 points, and 'rarely/never or does not apply to me' will receive 3 points. Per the REAP-S protocol, responses will be tabulated, and higher scores will indicate better diet quality.
Measured: Change from Baseline at week 8
Blood pressure
Both systolic and diastolic blood pressure will be obtained prior to blood draw. Participants will be instructed to sit quietly with their feet planted flat on the floor. After a 10-minute rest period, a non-invasive Omron auto cuff blood pressure monitor equipped with IntelliSense technology, which allows the machine to inflate and deflate at optimum levels depending on arm size, will be utilized to obtain blood pressure in mm Hg.
Measured: Change from Baseline at week 8
Blood lipids
. LDL and HDL cholesterol will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL). Triglycerides will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL).
Measured: Change from Baseline at week 8
Waist circumference
Waist circumference will be obtained to the nearest 5 cm using a research-grade ergonomic measuring tape placed horizontally around participants' natural waist (i.e., narrowest circumference above the umbilicus). Waist circumference will be measured twice and averaged unless the difference between the first and second measurement is above 5 cm. In that event, a third measurement will be obtained, and the mean of the nearest two circumferences will be recorded.
Measured: Change from Baseline at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start11 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8-week randomized-controlled, 2-arm parallel design trial
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348019
- Sponsor's protocol ID
- TRF-DQ
- Status last verified
- Nov 2021
- First submitted
- 13 Apr 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Matters: An 8-wk Randomized-Controlled Trial to Examine the Effects of a Daily Time-Restricted Feeding Protocol on Diet Quality
- ClinicalTrials.gov ID
- NCT04348019
- Acronym / sponsor ID
- TRF-DQ
- Conditions
- Diet, Healthy, Weight Change, Body, Dyslipidemias, Blood Pressure
- Keywords
- time restricted feeding, fasting, diet quality, body mass index, cardiometabolic biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a result of unhealthful lifestyle practices including nighttime ingestion and excess energy-dense food and beverage intake, college students are presenting with metabolic abnormalities and excess weight gain that increases their risk for chronic health conditions including cardiovascular diseases and type 2 diabetes. Research has shown that prolonging nightly fasting intervals can result in health improvements in both animal models and human subjects. Time-restricted feeding (TRF), a form of intermittent fasting may offer an exciting, non-pharmacologic approach to improve cardiometabolic health in this population by restricting food intake to feeding windows that align with circadian biology.
Detailed description
This 8-wk randomized-controlled, parallel arm trial will examine the effects of a daily 18 h fast (TRF protocol) compared to a daily 8-h (CON protocol) on (1) diet quality, (2) cardiometabolic health, and (3) anthropometry in college students enrolled at ASU. Institutional Review Board (IRB) approval will be granted prior to recruitment and commencement of trial activities. Participants will be stratified by age, waist circumference, gender, and METS (activity score) and randomly assigned to one of two study arms: intervention and control. [Women will begin the trial within 5 days of menses.] Participants in the intervention arm of the study will consume food and beverages of their choice within one hour of waking and the feeding window will extend 6 hours. Beyond these hours, participants will observe a prolonged fast (i.e., an 18-h overnight fast). Participants in the control arm of the study will fast each night for 8 hours. During fasting hours, participants will only be permitted to consume non-caloric beverages (preferably water only but unsweetened and non-caloric coffee, tea, etc. will be permitted). Participants will adhere to their daily protocol for 8 weeks. Participants will not receive diet instruction other than 'to fast' and are told to maintain their typical physical activity patterns for the duration of the trial. Participants will choose one 'cheat-day' per week where they are excused from the fasting protocols; this day of the week will be consistent throughout the 8-week trial. Diet quality will be measured by the REAP-S questionnaire, 24-h recalls will be obtained by a registered dietitian via a three-step multiple-pass interview method, a registered nurse or radiology technician will obtain fasting blood draws for biomarkers, and trained research personnel will obtain measures of anthropometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 8-week randomized-controlled, 2-arm parallel design trial
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding | Experimental | Behavioral: FastingParticipants in the intervention arm of the study will consume food and beverages of their choice within one hour of waking and the feeding window will extend 6 hours. Beyond these hours, participants will observe a prolonged fast (i.e., an 18-h overnight fast). |
| Control | Placebo comparator | Behavioral: FastingParticipants in the control arm of the study will fast each night for 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- healthy (no unresolved medical condition)
- non-smoking (includes vaping)
- normal to under-active (< 420 minutes of activity/week; not training for or competing in sports events)
- college students (≥18 years old)
- free of acute illnesses or diagnosed chronic diseases (by self-report)
Key exclusion criteria (5 listed)
- participants who regularly fast for >12 hours/d or adhere to a fasting regimen (i.e., alternate day fasting, Ramadan-style fasting, 5:2 fasting) at the time of screening or within the past six months
- those with weight loss attempt(s) or weight change (≥ 5 lbs.) within the past six months (including pregnancy)
- those with a history of weight cycling (repeated weight loss and weight gain over time)
- those who currently work night-shifts (i.e., midnight to 6AM), and those unwilling to adhere to the protocol will be excluded from the trial
- pregnant or lactating women, and women not on prescription contraceptives (i.e., birth control pills, IUDs, and patches) (however, if a female applicant states her menstrual cycle is regular, the need to be on prescription contraceptives will be waived)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingFasting was defined as no foods or caloric beverages. | Behavioural | Control, Time restricted feeding |
Primary outcome
Diet quality
Time frame: Change from Baseline at week 8
A REAP-S questionnaire will be completed for the previous week's intake during Trial Visits 1-3. The REAP-S questionnaire is a 16-item validated measure of diet quality whereby participants respond to questions that estimate the intake of fruits and vegetables, fiber, sugar, milk, fat, and dietary cholesterol. Responses of 'usually/often' will receive 1 point, 'sometimes' will receive 2 points, and 'rarely/never or does not apply to me' will receive 3 points. Per the REAP-S protocol, responses will be tabulated, and higher scores will indicate better diet quality.
Blood pressure
Time frame: Change from Baseline at week 8
Both systolic and diastolic blood pressure will be obtained prior to blood draw. Participants will be instructed to sit quietly with their feet planted flat on the floor. After a 10-minute rest period, a non-invasive Omron auto cuff blood pressure monitor equipped with IntelliSense technology, which allows the machine to inflate and deflate at optimum levels depending on arm size, will be utilized to obtain blood pressure in mm Hg.
Blood lipids
Time frame: Change from Baseline at week 8
. LDL and HDL cholesterol will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL). Triglycerides will be measured using a commercially available diagnostic test kit on a bench-top, fully automated, clinical chemistry analyzer (Randox Laboratories Ltd, Crumlin, UK), and results will be expressed in milligrams per deciliter (mg/dL).
Waist circumference
Time frame: Change from Baseline at week 8
Waist circumference will be obtained to the nearest 5 cm using a research-grade ergonomic measuring tape placed horizontally around participants' natural waist (i.e., narrowest circumference above the umbilicus). Waist circumference will be measured twice and averaged unless the difference between the first and second measurement is above 5 cm. In that event, a third measurement will be obtained, and the mean of the nearest two circumferences will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Diet, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Diet, Healthy and Weight Change, Body, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet quality (time frame: Change from Baseline at week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.